Micro-filament Intracranial Recording for Epilepsy

(NeuroSeizure Trial)

Overseen By Birgit Frauscher, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Adrien Peyrache

Must not be taking: Anti thrombotics

Disqualifiers: Severe psychiatric disorders, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

45 Participants Needed

Trial Summary

What is the purpose of this trial?

record fast ripples with novel intracranial electrodes with micro-tetrodes to improve the identification of epileptogenic zone (EZ) and investigate the neuronal circuits underlying brain dynamics associated with epilepsy

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on anti-thrombotic treatment (medications that prevent blood clots), you may not be eligible to participate.

What data supports the effectiveness of the treatment Macro-micro Tetrodes, Hybrid Electrodes, Macro-micro Depth Electrodes, Tetrode-equipped Electrodes for epilepsy?

Research shows that hybrid electrodes equipped with tetrodes can successfully record brain activity in epileptic patients, providing high-quality data that helps in understanding and treating epilepsy. These electrodes have been used to isolate neuron activity more effectively than traditional methods, which is crucial for identifying seizure origins and planning surgical interventions. ^{1 2 3 4 5}

Is the Micro-filament Intracranial Recording for Epilepsy generally safe for humans?

Research shows that intracranial electrode implantation, including micro-macroelectrodes, has a favorable safety profile with a low complication rate of 4.9%, and no permanent harm was recorded. Additionally, new thin-film electrodes have passed extensive safety tests and are FDA-cleared for human use, indicating they are safe for clinical practice. ^{1 6 7 8 9}

How is the Micro-filament Intracranial Recording for Epilepsy treatment different from other treatments for epilepsy?

This treatment uses hybrid electrodes equipped with tetrodes, which are more effective at isolating single neuron activity compared to traditional electrodes. This allows for more precise recording of brain activity, helping to better identify the areas responsible for seizures in epilepsy patients. ^{1 2 3 6 10}

Eligibility Criteria

This trial is for individuals with refractory epilepsy who are eligible for a special brain monitoring procedure called sEEG. It's not suitable for those with severe psychiatric issues, intense agitation during seizures, or conditions that prevent MRI scans like claustrophobia or certain implants.

Inclusion Criteria

I am eligible for a brain monitoring procedure.

My epilepsy does not improve with treatment.

Exclusion Criteria

I am not pregnant, nursing, or have severe health issues like heart, lung, kidney, or liver diseases.

Severe agitation during their crisis

Severe psychiatric disorders

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Monitoring

Patients are implanted with novel intracerebral micro-macroelectrodes to record fast ripples and single neuron activity

1 week

In-patient monitoring

Assessment

Evaluate the efficiency of microelectrodes compared to macroelectrodes in recording fast ripples

10 days

Follow-up

Participants are monitored for safety and effectiveness after the implantation and assessment phases

4 weeks

Treatment Details

Interventions

• Macro-micro Tetrodes

Trial Overview The study is testing new intracranial electrodes with micro-tetrodes to record 'fast ripples' in the brain. This could help better identify the epileptogenic zone and understand the neuronal circuits in epilepsy.

Participant Groups

Group I: micro-macroelectrodes Experimental Treatment 1 Intervention

Patients will be implanted with usually the novel intracerebral micro-macroelectrodes (instead of the regular clinical macroelectrodes). The primary and secondary outcomes will then be assessed.

Macro-micro Tetrodes is already approved in European Union, United States for the following indications:

Approved in European Union as Hybrid Electrodes for:

• Epilepsy diagnosis
• Epileptogenic zone identification

Approved in United States as Macro-micro Depth Electrodes for:

• Research use in epilepsy
• Investigational device for EZ identification

Who Is Running the Clinical Trial?

Adrien Peyrache

Lead Sponsor

Trials

1

Recruited

50+

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+

Findings from Research

The new hybrid electrode, which combines macroelectrodes and tetrodes, was safely implanted in 28 epileptic patients without any clinical complications, demonstrating its compatibility with clinical intracranial recordings.

This hybrid design allowed for effective isolation of single neuron activity, achieving a promising single-unit yield of over 10 neurons per tetrode, and provided unique spatial information that traditional macro-contacts could not capture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recording local field potential and neuronal activity with tetrodes in epileptic patients. Despouy, E., Curot, J., Reddy, L., et al.[2021]

A new hybrid depth electrode (HDE) method allows for high-quality in vivo microelectrode recordings from individual neurons in patients with epilepsy, enhancing the ability to study brain activity during clinical procedures.

In a study involving six patients with medically refractory epilepsy, the HDE provided excellent recordings over 5 to 14 days, enabling detailed physiological investigations while patients remained comfortable and cooperative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A hybrid clinical-research depth electrode for acute and chronic in vivo microelectrode recording of human brain neurons. Technical note. Howard, MA., Volkov, IO., Granner, MA., et al.[2006]

Intracerebral electrodes, which can be implanted for several days, provide a more precise localization of the epileptic focus compared to traditional scalp recordings, allowing for better mapping of the cortical epileptic network.

These electrodes not only enhance the understanding of epilepsy through high-resolution recordings but also enable direct cortical stimulation to identify critical brain areas, improving surgical outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Drug-resistant partial epilepsy. Invasive electrophysiological explorations]. Isnard, J.[2006]

In a study involving 17 patients with epilepsy who had not responded to medical treatment, chronic subdural strip electrodes were safely used to record seizure origins and map cortical areas, providing critical information for surgical planning.

Seizure origins were confirmed in 75% of patients through electrical stimulation, and the procedure also helped identify speech areas in 50% of cases, highlighting its efficacy in improving surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subdural recording and electrical stimulation for cortical mapping and induction of usual seizures. De Salles, AA., Swartz, BE., Lee, TT., et al.[2018]

Over one third of the 60 million people with epilepsy experience uncontrolled seizures, and current surgical options only lead to seizure freedom in about 35% of cases, highlighting the urgent need for new treatments.

The research team has developed innovative implantable brain devices using flexible silicon nanoribbons that can record from very small brain regions with high precision, potentially enabling better mapping of epileptic networks and improving treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of high resolution, multiplexed electrode arrays: Opportunities and challenges. Viventi, J., Blanco, JA.[2021]

The multicontact macroelectrode features a hollow-core design and recessed contacts, which minimizes tissue trauma during brain recordings, making it safer for patients.

Its helical structure provides high flexibility and fatigue resistance, allowing it to move with the brain, which is particularly beneficial in clinical applications for epileptic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multipolar hollow-core electrode for brain recordings. Comte, P., Siegfried, J., Wieser, HG.[2019]

In a study of 163 intracranial electrode implantation procedures for drug-resistant focal epilepsy, the overall complication rate was low at 4.9%, with no permanent morbidity or mortality reported, indicating a favorable safety profile for this intervention.

Major complications were more likely in patients with MRI-negative cases, suggesting that careful patient selection may further enhance safety when considering invasive exploration for epilepsy treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of intracranial electrode implantation for video-EEG recordings in drug-resistant focal epilepsy. Mathon, B., Clemenceau, S., Hasboun, D., et al.[2018]

New thin-film polyimide electrodes (0.08 mm) for invasive electroencephalography have been developed and cleared by the FDA for clinical use, demonstrating significant improvements over traditional thicker electrodes in terms of biocompatibility and conformability to brain structures.

Biocompatibility tests showed that these electrodes are non-cytotoxic, non-mutagenic, and do not cause irritation or sensitization, making them safe for use in patients with drug-resistant epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Food and Drug Administration Cleared Thin-Film Electrode for Intracranial Stimulation, Recording, and Monitoring of Brain Activity-Part 1: Biocompatibility Testing. Kullmann, A., Kridner, D., Mertens, S., et al.[2022]

A new depth EEG electrode design has been developed that allows for safe insertion and artifact-free recordings, enhancing the ability to localize seizure origins in epilepsy patients.

In a study involving seven patients over 2600 hours of implantation, the electrode showed no complications such as hemorrhage, edema, or infection, and it provided accurate positioning within critical brain areas like the amygdala and hippocampus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a depth electroencephalography electrode. Maxwell, RE., Gates, JR., Fiol, ME., et al.[2019]

The custom-made tetrode microdrive allows for simultaneous recording of large populations of neurons from multiple brain areas in nonhuman primates, enabling detailed study of neural activity during behavioral tasks.

This technology facilitates the investigation of interactions between well-isolated neuron ensembles across different regions, which is crucial for understanding neural circuits related to human neurological disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel tetrode microdrive for simultaneous multi-neuron recording from different regions of primate brain. Santos, L., Opris, I., Fuqua, J., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Recording local field potential and neuronal activity with tetrodes in epileptic patients. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A hybrid clinical-research depth electrode for acute and chronic in vivo microelectrode recording of human brain neurons. Technical note. [2006]

3. France pubmed.ncbi.nlm.nih.gov

[Drug-resistant partial epilepsy. Invasive electrophysiological explorations]. [2006]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Subdural recording and electrical stimulation for cortical mapping and induction of usual seizures. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Development of high resolution, multiplexed electrode arrays: Opportunities and challenges. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Multipolar hollow-core electrode for brain recordings. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Safety profile of intracranial electrode implantation for video-EEG recordings in drug-resistant focal epilepsy. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

First Food and Drug Administration Cleared Thin-Film Electrode for Intracranial Stimulation, Recording, and Monitoring of Brain Activity-Part 1: Biocompatibility Testing. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a depth electroencephalography electrode. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

A novel tetrode microdrive for simultaneous multi-neuron recording from different regions of primate brain. [2021]